Clinical Trials Logo
  1. Home
  2. Infants
  3. NCT02069522
  4. Details
NCT02069522 Clinical Trial

Healthy Term Infants Fed Milk-Based Formulas

Infants Clinical Trial

Official title:
Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02069522
Other study ID # AL13
Secondary ID
Status Terminated
Phase N/A
First received February 18, 2014
Last updated March 20, 2015
Start date February 2014
Est. completion date February 2015

Study information
Verified date March 2015
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

Recruitment information / eligibility
Status Terminated
Enrollment 91
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- Infant is in good health

- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks

- Infant's birth weight was > 2490 g (~5 lbs 8 oz)

- Infant is between 14 and 28 days of age

- Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study

- Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion Criteria:

- An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.

- Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Other:
• Standard Milk-based Formula Containing Carotenoid
Fed ad libitum
• Investigational Milk-based Formula Containing Carotenoid
Fed ad libitum

Locations
Country Name City State
United States MetroHealth Medical Center Cleveland Ohio
United States Dayton Clinical Research Dayton Ohio
United States Northpoint Pediatrics Indianapolis Indiana
United States Midwest Children's Health Research Institute Lincoln Nebraska
United States Institute of Clinical Research Mayfield Heights Ohio
United States Tuscon Medical Center Tuscon Arizona

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Carotenoid Concentration Plasma sample Change from Baseline to end of Study Period A (~21 Days) No
Secondary Carotenoid Concentration Plasma sample Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days) No
See also
  Status Clinical Trial Phase
Withdrawn NCT01953562 - Positioning and the Spontaneous Breathing Test in Neonates N/A
Completed NCT03716882 - Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification
Recruiting NCT06353841 - Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children N/A
Completed NCT06447558 - The Effects of "Oral Administration of Breast Milk Droplets" and "Palatal Stimulation With a Finger" N/A
Recruiting NCT05705258 - A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)
Not yet recruiting NCT06319079 - Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition N/A
Completed NCT02119104 - Prevenar (13v) Infant Drug Use Investigation N/A
Recruiting NCT06318858 - Daily and Weekly Iron Supplementation in Infants N/A
Not yet recruiting NCT03047876 - Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery
Withdrawn NCT05266677 - DHA Proof-of-Concept Study in Infants and Toddlers N/A
Recruiting NCT05940688 - Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study N/A
Not yet recruiting NCT06127914 - Learning Early Infant Feeding Cues N/A
Completed NCT05492253 - First Complementary Foods and the Infant Gastrointestinal Microbiota N/A
Completed NCT03327415 - Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children N/A
Completed NCT04598841 - Nutrition Support for Hirschsprung Disease N/A
Completed NCT01664234 - Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children N/A
Completed NCT04218929 - Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants N/A
Recruiting NCT01575184 - Effect of Shoulder Traction on Size and Relative Position of Internal Jugular Vein to Carotid Artery N/A
Not yet recruiting NCT05994417 - Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants